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FDA 510(k) Application Details - K203126
Device Classification Name
Ventilator, Non-Continuous (Respirator)
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510(K) Number
K203126
Device Name
Ventilator, Non-Continuous (Respirator)
Applicant
ResMed Pty Ltd
1 Elizabeth Macarthur Drive
Bella Vista 2053 AU
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Contact
Peter Jennings
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Regulation Number
868.5905
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Classification Product Code
BZD
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More FDA Info for this Product Code
Date Received
10/19/2020
Decision Date
12/18/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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